CN112190681A

CN112190681A - Traditional Chinese medicine composition for treating ulcerative colitis and preparation method thereof

Info

Publication number: CN112190681A
Application number: CN202011180106.6A
Authority: CN
Inventors: 李军祥
Original assignee: DONGFANG HOSPITAL BEIJING UNIVERSITY OF CHINESE MEDICINE
Current assignee: DONGFANG HOSPITAL BEIJING UNIVERSITY OF CHINESE MEDICINE
Priority date: 2020-10-29
Filing date: 2020-10-29
Publication date: 2021-01-08

Abstract

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating ulcerative colitis and a preparation method thereof. The traditional Chinese medicine composition comprises the following components: dark plum, coptis root, golden cypress, asarum, pepper, baked ginger, cassia twig, prepared aconite, costus root, lightyellow sophora root, natural indigo, pseudo-ginseng, carbonized sanguisorba root, Chinese pulsatilla root, ash bark and honey-fried licorice root. The Chinese medicinal composition has good effect of treating ulcerative colitis (especially severe ulcerative colitis and intractable ulcerative colitis), low recurrence rate and no obvious side effect.

Description

Traditional Chinese medicine composition for treating ulcerative colitis and preparation method thereof

Technical Field

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating ulcerative colitis and a preparation method thereof.

Background

Ulcerative Colitis (UC) is a chronic non-specific inflammatory disease with an undefined etiology and well developed in the colon and rectum, and mainly affects the young and middle-aged people of 15-40 years old. Ulcerative colitis belongs to a life-long disease, and clinical symptoms of diarrhea, mucus, bloody stool, abdominal pain and the like seriously affect the life quality of patients. The incidence and prevalence of ulcerative colitis have a tendency to increase year by year, and clinically severe ulcerative colitis is not rare. Usually, the use of glucocorticoids (hereinafter referred to as hormones) is the first line of treatment for severe ulcerative colitis, but more than 30% of patients are hormone resistant, known as refractory ulcerative colitis (RSUC). The intractable ulcerative colitis patient mainly refers to a patient with 10-12 points of Mayo score and more than or equal to 2 points of endoscopic score, glucocorticoid dependence exists, or at least one of the conventional treatment medicines such as oral aminosalicylic acid preparation, glucocorticoid or immunosuppression has no response or is not tolerant. In combination with the manifestations of ulcerative colitis, TCM believes that ulcerative colitis belongs to the category of "intestinal " and "chronic dysentery". Mucopurulent blood is an important manifestation of the disease in the active stage, and other symptoms include abdominal pain, nausea, vomiting, weight loss, tenesmus and the like, and sometimes are accompanied by parenteral manifestations such as peripheral arthritis, episcleritis, oral ulcer, skin lesion and the like, and general manifestations such as fever, anemia and the like in the active stage of medium and heavy patients. In most patients, the disease is manifested as chronic and low malignancy, and a few patients have acute onset, with occasional acute outbreak. These patients with severe ulcerative colitis present with frequent bloody stools, up to 30 times per day, and high fever, abdominal pain. Meanwhile, the physical signs are directly related to the disease period and clinical manifestations, patients often have weight loss and pale complexion, the colon part is often tender during abdominal examination in the disease activity period, acute abdomen symptoms are possibly accompanied by fever and reduction of bowel sounds, the acute attack or fulminant cases are particularly obvious, and the toxic megacolon can be accompanied by abdominal distension, fever and acute abdomen symptoms. Perianal skin can be abraded, denuded due to frequent diarrhea. Such patients face the embarrassment of no available drugs due to poor therapeutic effect or adverse drug reactions of conventional drugs. With the recent year-by-year increase of the incidence rate of ulcerative colitis, the important significance of research on therapeutic drugs thereof is highlighted.

At present, aminosalicylic acid drugs are clinically common drugs for treating mild and moderate ulcerative colitis, and comprise salicylic acid sulfasalazine (SASP), 5-aminosalicylic acid (5-ASA) and the like, which have many adverse reactions, such as nausea, vomiting, hemolysis and the like, and have poor curative effect on part of patients. The use of hormones (such as prednisolone, dexamethasone, hydrocortisone, etc.) is the first-line treatment scheme for severe ulcerative colitis, but more than 30% of patients are resistant to hormones and have better effect only on short-term symptom relief, part of the drugs have the defects of low bioavailability, more intestinal tract residues, and the like, and long-term administration of hormone drugs aggravates or induces infection, and delayed onset and yin-attacking adverse reactions, which are most related to accumulation, appear.

In the prior art, many of the traditional Chinese medicines for treating ulcerative colitis are disclosed, for example, in general findings of experts in traditional Chinese medicine diagnosis and treatment for ulcerative colitis (2017), the traditional Chinese medicine treatment is generally classified into main symptoms of large intestine damp-heat syndrome according to syndrome differentiation: diarrhea, pus and blood in the mucous under the stool; abdominal pain; tenesmus after tenesmus. The secondary symptoms are as follows: burning of the anus; abdominal distension; scanty and brownish urine; dry mouth and bitter taste. Heat-clearing and dampness-resolving, qi-regulating and blood-regulating should be given as the main recipe in Shao Yao Tang. The predominant syndrome of toxic heat: pus and blood in the stool or bloody stool frequently; the abdominal pain is obvious; generating heat. The secondary symptoms are as follows: tenesmus after tenesmus; abdominal distension; thirst; restlessness. For clearing heat and eliminating dampness, cooling blood and removing toxicity, Bai Tou Weng Tang is used as the main prescription. The main symptoms of spleen deficiency and dampness accumulation syndrome: pus, bloody stool, white, more red and less red in mucus or white jelly; loose stool with undigested food; abdominal distention and fullness. The secondary symptoms are as follows: dull pain in the abdomen; drowsiness of the limbs; poor appetite and anorexia; lassitude and laziness in speaking. Qi tonifying and spleen invigorating, dampness resolving and middle warmer regulating are appropriate, and Shen Ling Bai Zhu san is the main formula. The main symptoms of the cold-heat intermingled syndrome are: diarrhea with sticky and cold sensation, repeated attack; burning of the anus; the abdominal pain is continuous. The secondary symptoms are as follows: intolerance of cold; thirst without desire for drink; hunger without appetite. It is advisable to warm the middle energizer and tonify deficiency, clear heat and resolve dampness. The dark plum pill is taken as a main formula. Liver stagnation and spleen deficiency syndrome: emotional depression or anxiety, frequent defecation is often induced by emotional factors; stool rotten or mucous stool; abdominal pain is diarrhea immediately, and pain is relieved after diarrhea. The secondary symptoms are as follows: the defecation is not comfortable; a decrease in diet; abdominal distension; borygmus. It is advisable to soothe the liver, regulate qi, invigorate spleen and resolve dampness, and the main prescriptions are pain-relieving and diarrhea-relieving combined with Siqisan. The main symptoms of the spleen-kidney yang deficiency syndrome are: persistent diarrhea and loose stool; white frost is accompanied by or accompanied by rice-grain indigestion, even slippage is prohibited; abdominal pain is relieved with warmth and pressure. The secondary symptoms are as follows: abdominal distension; poor appetite and anorexia; cold in shape and cold in limbs; soreness and weakness of waist and knees. Spleen invigorating, kidney tonifying, yang warming, dampness resolving, and Fu Zi Lizhong Wan and Sishen Wan are used as main prescriptions. The main symptoms of yin-blood deficiency syndrome: pus and blood in the stool and attack repeatedly; the dry stool with mucus and bloody stool and unsmooth defecation; there is dull burning pain in the abdomen. The secondary symptoms are as follows: emaciation; dry mouth and throat; restlessness and insomnia due to deficiency; feverish sensation in the chest, palms and soles. It is suitable for nourishing yin, clearing intestine, benefiting qi and nourishing blood, and uses Zhu Bi Wan and Siwu Tang as main ingredients. However, the action advantages and links of the existing traditional Chinese medicine formulas in mild, moderate and severe ulcerative colitis are still unclear, the application of the traditional Chinese medicine formulas for severe or intractable ulcerative colitis is not yet available (only the empirical formula of self-prepared intestine-cleaning and ulcer-healing decoction such as gao ming and the like is used for improving the clinical symptoms of patients with severe or intractable ulcerative colitis through traditional Chinese medicine internal and external treatment and enema), and a traditional Chinese medicine composition for assisting in treating severe or intractable ulcerative colitis through oral administration of pure traditional Chinese medicine formulas is not available.

In view of this, the invention is particularly proposed.

Disclosure of Invention

In order to overcome the defects of poor curative effect, high recurrence rate, obvious side effect and the like of the medicines for treating ulcerative colitis (especially severe ulcerative colitis and intractable ulcerative colitis) in the prior art, the invention researches the pathogenesis of ulcerative colitis (especially severe ulcerative colitis and intractable ulcerative colitis), and through long-term and large-scale clinical observation, practice and discovery, the pathogenesis is mainly spleen-kidney yang deficiency, damp-heat in intestinal tract is the secondary aspect, and the key pathogenesis is cold-heat complicated and damp-heat stasis.

Based on the findings, the invention provides a traditional Chinese medicine composition for treating ulcerative colitis and a preparation method thereof. The Chinese medicinal composition has good effect of treating ulcerative colitis (especially severe ulcerative colitis and intractable ulcerative colitis), low recurrence rate and no obvious side effect.

The invention provides a traditional Chinese medicine composition for treating ulcerative colitis, which comprises the following components: dark plum, coptis root, golden cypress, asarum, pepper, baked ginger, cassia twig, prepared aconite, costus root, lightyellow sophora root, natural indigo, pseudo-ginseng, carbonized sanguisorba root, Chinese pulsatilla root, ash bark and honey-fried licorice root.

Specifically, the traditional Chinese medicine composition comprises the following components in parts by weight: 10-15 parts of dark plum fruit, 5-10 parts of coptis chinensis, 7-11 parts of golden cypress, 2-5 parts of asarum, 7-15 parts of pepper, 5-10 parts of baked ginger, 10-15 parts of cassia twig, 5-10 parts of prepared aconite, 5-10 parts of elecampane, 5-10 parts of sophora flavescens, 2-5 parts of indigo naturalis, 5-10 parts of pseudo-ginseng, 10-15 parts of garden burnet root charcoal, 10-15 parts of Chinese pulsatilla root, 10-15 parts of ash bark and 5-10 parts of honey-fried licorice root.

Preferably, the traditional Chinese medicine composition consists of the following components in parts by weight: 10-13 parts of dark plum fruit, 5-8 parts of coptis chinensis, 8-11 parts of golden cypress, 2-4 parts of asarum, 7-10 parts of pepper, 5-9 parts of baked ginger, 10-13 parts of cassia twig, 7-10 parts of prepared aconite, 5-8 parts of elecampane, 5-9 parts of sophora flavescens, 2-4 parts of indigo naturalis, 5-8 parts of pseudo-ginseng, 12-15 parts of garden burnet root charcoal, 12-15 parts of Chinese pulsatilla root, 10-13 parts of ash bark and 5-8 parts of honey-fried licorice root.

More preferably, the traditional Chinese medicine composition consists of the following components in parts by weight: 11-13 parts of dark plum fruit, 5-7 parts of coptis chinensis, 9-11 parts of golden cypress, 2-4 parts of asarum, 8-10 parts of pepper, 8-9 parts of baked ginger, 10-11 parts of cassia twig, 9-10 parts of prepared aconite, 5-7 parts of elecampane, 8-9 parts of radix sophorae flavescentis, 2-4 parts of indigo naturalis, 5-7 parts of pseudo-ginseng, 14-15 parts of carbonized sanguisorba root, 14-15 parts of Chinese pulsatilla root, 10-11 parts of ash bark and 5-7 parts of honey-fried licorice root.

As the best technical scheme of the invention, the traditional Chinese medicine composition comprises the following components in parts by weight: 12 parts of dark plum fruit, 6 parts of coptis chinensis, 10 parts of golden cypress, 3 parts of asarum, 9 parts of pepper, 9 parts of baked ginger, 10 parts of cassia twig, 10 parts of prepared aconite, 6 parts of costustoot, 9 parts of sophora flavescens, 3 parts of indigo naturalis, 6 parts of pseudo-ginseng, 15 parts of carbonized sanguisorba root, 15 parts of Chinese pulsatilla root, 10 parts of ash bark and 6 parts of honey-fried licorice root.

The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: the components are mixed evenly according to the mixture ratio and sieved by a sieve with 100 to 150 meshes.

Preferably, the components are respectively crushed into fine powder and then uniformly mixed according to the proportion, or the components are uniformly mixed according to the proportion and then crushed into fine powder and sieved by a sieve with 100-150 meshes.

The invention also provides another preparation method of the traditional Chinese medicine composition, which comprises the following steps: mixing the above components at a certain ratio, decocting with water 8-12 times of the weight of the medicinal materials for 1.5-2.5 hr, decocting with water 6-10 times of the weight of the medicinal materials for 1-2 hr, and filtering; preferably, the filtrate is concentrated to an extract with the relative density of 1.2-1.25 at 50-70 ℃.

Preferably, the method comprises the steps of: mixing the above components at a certain ratio, decocting with water 10 times of the weight of the raw materials for 2 hr, decocting with water 8 times of the weight of the raw materials for 1.5 hr, filtering, and concentrating the filtrate at 60 deg.C to obtain extract with relative density of 1.2-1.25.

The invention also provides another preparation method of the traditional Chinese medicine composition, which comprises the following steps: mixing the above components at a certain ratio, soaking in 55-75% ethanol 4-12 times the weight of the raw materials for 12-48 hr, heating the medicinal liquid to 30-40 deg.C, and forcibly circulating for 3-4 hr.

Preferably, the method comprises the steps of: the components are uniformly mixed according to the proportion, crushed into coarse powder, soaked in 60 percent ethanol which is 8 times of the weight of the medicinal materials for 30 hours, and then the liquid medicine is heated to 35 ℃ and is forcedly circulated for 3.5 hours.

In the above technical solution, the forced circulation may be performed in a forced circulation evaporator.

The invention also provides a preparation containing the traditional Chinese medicine composition, and the preparation is prepared from the traditional Chinese medicine composition separately; or comprises a traditional Chinese medicine composition and a pharmaceutically acceptable carrier; or comprises a traditional Chinese medicine composition and auxiliary materials, wherein the auxiliary materials are one or more of dextrin, lactose, sucrose and soluble starch.

Preferably, the formulation is a granule, capsule, pill or suppository.

The formulation of the invention is preferably a granulate.

The invention also provides a preparation method of the preparation, which comprises the following steps:

(1) preparing a traditional Chinese medicine composition;

(2) the traditional Chinese medicine composition and a pharmaceutically acceptable carrier or auxiliary material are prepared into a preparation.

The invention also provides application of the traditional Chinese medicine composition or the preparation in preparing a medicine for treating ulcerative colitis.

Preferably, the ulcerative colitis is severe ulcerative colitis or refractory ulcerative colitis.

The traditional Chinese medicine composition provided by the invention has the following advantages:

1. the traditional Chinese medicine composition with the effect of treating ulcerative colitis comprises dark plum, coptis chinensis, golden cypress, asarum, pepper, baked ginger, cassia twig, prepared aconite, elecampane, radix sophorae flavescentis, indigo naturalis, pseudo-ginseng, carbonized sanguisorba root, Chinese pulsatilla root, ash bark and honey-fried licorice root. Based on the knowledge of the pathogenesis of the ulcerative colitis, the traditional Chinese medicine has the effects of clearing heat, eliminating dampness, detoxifying, removing blood stasis, warming kidney and strengthening spleen. The dark plum, the coptis and the Chinese pulsatilla root are monarch drugs: dark plum is sour, astringent and antidiarrheal, coptis root is heat-clearing, dampness-drying, fire-purging and detoxifying, Chinese pulsatilla root is heat-clearing, detoxifying and dysentery-stopping, and the three medicines are monarch medicines together; indigo naturalis, radix sophorae flavescentis, pseudo-ginseng, baked ginger and prepared aconite root are used as ministerial drugs: indigo naturalis has effects of clearing heat and detoxicating, cooling blood and subsiding swelling, astringing ulcer, Sophorae radix has effects of clearing heat and eliminating dampness, Notoginseng radix has good effect of stopping bleeding, and has effects of stopping bleeding without stasis, processing rhizoma Zingiberis Preparata, warming channels and stopping bleeding, warming middle-jiao and relieving pain, and making radix Aconiti lateralis Preparata to warm and tonify kidney yang; cortex Phellodendri, cortex Fraxini, herba asari, fructus Zanthoxyli, ramulus Cinnamomi, radix aucklandiae, and charred radix Sangusorbae as adjuvant drugs: phellodendron bark, cortex fraxini, herba asari, radix aucklandiae and radix Sanguisorbae, cortex Phellodendri, cortex Fraxini, herba asari, radix aucklandiae, radix Sanguisorbae, radix rehmanniae Preparata, radix rehmanniae Preparata; prepared licorice root is used as a guiding drug: prepared licorice root, radix Glycyrrhizae Praeparata, as a whole, has the effects of tonifying spleen and qi, relieving spasm and pain, and harmonizing the drugs in the recipe. The combination of the medicines can achieve the effects of clearing heat and eliminating dampness, detoxifying and removing blood stasis, and warming kidney and invigorating spleen, thereby achieving the purposes of relieving the pain of diseases, improving the life quality and prolonging the survival time.

2. The effect of the invention is investigated by establishing a chronic experimental colitis mouse model which is commonly used for researching the pathological mechanism of ulcerative colitis and evaluating anti-inflammatory drugs. The main principle is that the medicine is administrated after the modeling is successful, and the curative effect of the medicine is evaluated by observing the organism condition of animals.

The experimental result shows that the adhesion between the colon and the surrounding tissues of the chronic experimental colitis mouse using the traditional Chinese medicine composition is lighter, the congestion and the edema of the colon surface are reduced, and the level of the colonic mucosa injury index (CMD I) is obviously different from that of a blank group; the traditional Chinese medicine composition disclosed by the invention can lower the infiltration degree of inflammatory cells, reduce the expression of intestinal mucosa inflammatory mediators and repair the intestinal barrier function. The pharmacodynamic action of the traditional Chinese medicine composition for mainly treating the ulcerative colitis is preliminarily determined from the modern pharmacology perspective.

3. The preparation process provided by the invention is simple, convenient and quick, and the obtained preparation is convenient to store, good in stability and high in safety.

Drawings

FIG. 1 is a DSS molding timing chart in Experimental example 1.

FIG. 2 is a graph showing the effect of the drug on the body weight of mice induced with DSS in Experimental example 1.

FIG. 3 is a graph showing the effect of the drug in Experimental example 1 on HS in mice with DSS-induced colitis.

FIG. 4 is a schematic diagram showing the effect of the drug in Experimental example 1 on TNF-alpha, IFN-gamma and IL-17A, IL-6 in intestinal mucosa of mice with DSS-induced colitis.

FIG. 5 is a graph showing the effect of the drug in Experimental example 1 on the intestinal barriers E-cadherin, occlusin, ZO-1 of DSS-induced colitis mice.

Detailed Description

The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.

Example 1: traditional Chinese medicine composition for treating ulcerative colitis

1. Consists of the following components: 12 parts of dark plum fruit, 6 parts of coptis chinensis, 10 parts of golden cypress, 3 parts of asarum, 9 parts of pepper, 9 parts of baked ginger, 10 parts of cassia twig, 10 parts of prepared aconite, 6 parts of costustoot, 9 parts of sophora flavescens, 3 parts of indigo naturalis, 6 parts of pseudo-ginseng, 15 parts of carbonized sanguisorba root, 15 parts of Chinese pulsatilla root, 10 parts of ash bark and 6 parts of honey-fried licorice root.

2. The preparation method comprises the following steps: mixing the above components at a certain ratio, decocting with water 10 times of the weight of the raw materials for 2 hr, decocting with water 8 times of the weight of the raw materials for 1.5 hr, filtering, and concentrating the filtrate at 60 deg.C to obtain extract with relative density of 1.2-1.25.

Example 2: traditional Chinese medicine composition for treating ulcerative colitis

1. Consists of the following components: 11 parts of dark plum fruit, 7 parts of coptis chinensis, 9 parts of golden cypress, 3 parts of asarum, 9 parts of pepper, 8 parts of baked ginger, 11 parts of cassia twig, 9 parts of prepared aconite, 7 parts of costustoot, 8 parts of sophora flavescens, 2 parts of indigo naturalis, 6 parts of pseudo-ginseng, 15 parts of carbonized sanguisorba root, 15 parts of Chinese pulsatilla root, 10 parts of ash bark and 7 parts of honey-fried licorice root.

2. The preparation method comprises the following steps: pulverizing the above materials into fine powder, mixing, and sieving with 100-150 mesh sieve.

Example 3: traditional Chinese medicine composition for treating ulcerative colitis

1. Consists of the following components: 13 parts of dark plum fruit, 5 parts of coptis chinensis, 10 parts of golden cypress, 2 parts of asarum, 9 parts of pepper, 8 parts of baked ginger, 10 parts of cassia twig, 9 parts of prepared aconite, 6 parts of costustoot, 8 parts of sophora flavescens, 4 parts of indigo naturalis, 6 parts of pseudo-ginseng, 14 parts of carbonized sanguisorba root, 15 parts of Chinese pulsatilla root, 11 parts of ash bark and 6 parts of honey-fried licorice root.

2. The preparation method comprises the following steps: the components are uniformly mixed according to the proportion, crushed into coarse powder, soaked in 60 percent ethanol which is 8 times of the weight of the medicinal materials for 30 hours, the liquid medicine is heated to 35 ℃, and is forcedly circulated for 3.5 hours and filtered.

Example 4: granules

1. Consists of the following components: 20g of extract powder and 30g of dextrin.

2. The preparation method comprises the following steps: the extract prepared in the embodiment 1 is dried in vacuum at the temperature of below 60 ℃ to obtain dry extract, the dry extract is crushed and sieved by a 40-mesh sieve to obtain dry extract powder, and 20g of the dry extract powder is weighed for standby;

adding dextrin, making into soft mass with 85% ethanol as wetting agent, sieving with 16 mesh sieve, granulating, oven drying at 30-40 deg.C, grading, and packaging.

Experimental example 1: pharmacodynamic experiment

The effect of the present invention will be described below by experimental data (experimental drug is the granule obtained in example 4 of the present invention).

Experiment aim the treatment effect of the granules is verified by using a mouse model of chronic experimental colitis.

1. Experimental drugs: mesalazine enteric-coated tablets (manufacturer: LOSAN Pharma GmbH, batch number: H20171358); granules obtained in example 4.

2. Experimental animals: healthy male C57BL/6 mice, 30, weigh 20 soil 2g, class SPF rating.

3. Grouping experiments: after 7 days of animal acclimation, experimental animals were randomly divided into 3 groups: blank group, experimental group, control group.

4. Establishing a mouse model of chronic experimental colitis: the 3 groups of experimental animals are molded according to the molding method in the prior literature; the method specifically comprises the following steps: as shown in fig. 1, experimental animals were fed with 3% DSS solution for 7 days, deionized water for 14 days, DSS solution for 7 days, and conventionally; after the molding is finished, 3 mice are taken out immediately and then are killed, colon tissues are separated and checked, and obvious colon mucosa injuries are generated, so that the success of molding is prompted.

5. The administration method comprises the following steps: the blank group was given 0.1ml/g mouse body weight of deionized water; the mesalazine enteric-coated tablets and the granules prepared in example 4 are respectively administered to a control group and an experimental group, wherein the dosage of each administration of the control group is 0.32g/kg of mouse body weight, and the dosage of each administration of the experimental group is 14.49g/kg of mouse body weight. The administration is performed by intragastric administration, 1 time per day, and 10 days continuously.

6. Results and conclusions

1) Observation of therapeutic efficacy of DSS-induced Experimental colitis mice

Influence on weight of mice with experimental colitis induced by DSS

As shown in figure 2, after the model is made, the blank mice have diarrhea, namely bloody purulent stool, and the hair color of the mice is lusterless, the activity is poor, the reaction is slow, the movement is intermittent, and the weight is obviously reduced by 3 days. The mice in the experimental group have better spirit, gradually glossy hair, increased appetite, gradually increased activity, gradually normal stool and obvious weight regain, and have the same trend with the mice in the control group.

Secondly, as shown in fig. 3, congestion and edema of mucous membrane and a large amount of inflammatory cell infiltration can be seen under a blank group of light microscope, the infiltration of lymphocytes and neutrophils is taken as the main, and the depth of pathological changes reaches submucosa, muscular layer and even serosal layer; the goblet cells are obviously reduced, the glands around the ulcer are expanded, the arrangement of the glands is disordered, the glandular epithelial cells are slightly hyperplastic, and the inflammatory granuloma can be seen as the gland is accompanied by gland atypical hyperplasia. The congestion and edema under the optical lens of the experimental group are reduced, inflammatory cell infiltration is reduced, lymphocytes and plasma cells are taken as main cells, neutrophilic granulocytes are rare, eosinophilic granulocytes are visible in individual colon tissues, inflammatory cell infiltration layers are shallow, and the inflammatory cell infiltration layers are concentrated in submucosa.

2) Effect of mouse intestinal mucositis factors IFN-gamma, TNF-alpha and IL-17A, IL-6

As shown in figure 4, the levels of IFN-gamma, TNF-alpha and IL-17A, IL-6 of the intestinal mucosa of the colitis mice in the blank group are obviously higher than those in the experimental group (P < 0.05); the experimental group has a significant reduction (P <0.05) compared with the blank group, IL-6 also has a significant reduction (P <0.05) compared with the control group, and IFN-gamma, TNF-alpha and IL-17A have no significant difference (P >0.05) compared with the control group.

3) Effect of the intestinal Barrier in mice E-cadherin, ocludin, ZO-1

As shown in figure 5, the levels of E-cadherin, ZO-1 and occludin of the intestinal mucosa of the colitis mice in the experimental group are obviously higher than those of the intestinal mucosa of the colitis mice in the blank group (P < 0.05); compared with the blank group, the experimental group has obvious improvement effect (P <0.05), and ZO-1 and occludin have no obvious difference (P >0.05) from the control group.

In conclusion, the traditional Chinese medicine composition provided by the invention has a protection effect on intestinal mucosa of a DSS-induced colitis mouse, and can effectively improve the infiltration of colonic tissue inflammation cells. The traditional Chinese medicine composition can play a role in resisting inflammation on DSS-induced colitis mice by reducing the IFN-gamma, TNF-alpha and IL-17A, IL-6 levels of the intestinal mucosa and can protect the intestinal mucosa by increasing the expression of intestinal barrier E-cadherin and ZO-1.

The above experiments illustrate that: the traditional Chinese medicine composition provided by the invention can be used for treating ulcerative colitis, has a definite curative effect, and is superior to the prior art.

Although the invention has been described in detail hereinabove by way of general description, specific embodiments and experiments, it will be apparent to those skilled in the art that many modifications and improvements can be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims

1. A traditional Chinese medicine composition for treating ulcerative colitis is characterized by comprising the following components: dark plum, coptis root, golden cypress, asarum, pepper, baked ginger, cassia twig, prepared aconite, costus root, lightyellow sophora root, natural indigo, pseudo-ginseng, carbonized sanguisorba root, Chinese pulsatilla root, ash bark and honey-fried licorice root.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following components in parts by weight: 10-15 parts of dark plum fruit, 5-10 parts of coptis chinensis, 7-11 parts of golden cypress, 2-5 parts of asarum, 7-15 parts of pepper, 5-10 parts of baked ginger, 10-15 parts of cassia twig, 5-10 parts of prepared aconite, 5-10 parts of elecampane, 5-10 parts of sophora flavescens, 2-5 parts of indigo naturalis, 5-10 parts of pseudo-ginseng, 10-15 parts of garden burnet root charcoal, 10-15 parts of Chinese pulsatilla root, 10-15 parts of ash bark and 5-10 parts of honey-fried licorice root.

3. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following components in parts by weight: 10-13 parts of dark plum fruit, 5-8 parts of coptis chinensis, 8-11 parts of golden cypress, 2-4 parts of asarum, 7-10 parts of pepper, 5-9 parts of baked ginger, 10-13 parts of cassia twig, 7-10 parts of prepared aconite, 5-8 parts of elecampane, 5-9 parts of sophora flavescens, 2-4 parts of indigo naturalis, 5-8 parts of pseudo-ginseng, 12-15 parts of garden burnet root charcoal, 12-15 parts of Chinese pulsatilla root, 10-13 parts of ash bark and 5-8 parts of honey-fried licorice root.

4. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following components in parts by weight: 11-13 parts of dark plum fruit, 5-7 parts of coptis chinensis, 9-11 parts of golden cypress, 2-4 parts of asarum, 8-10 parts of pepper, 8-9 parts of baked ginger, 10-11 parts of cassia twig, 9-10 parts of prepared aconite, 5-7 parts of elecampane, 8-9 parts of radix sophorae flavescentis, 2-4 parts of indigo naturalis, 5-7 parts of pseudo-ginseng, 14-15 parts of carbonized sanguisorba root, 14-15 parts of Chinese pulsatilla root, 10-11 parts of ash bark and 5-7 parts of honey-fried licorice root.

5. A method of preparing the Chinese medicinal composition of any one of claims 1-4, comprising the steps of: mixing the components uniformly according to the proportion, and sieving the mixture by a sieve of 100-150 meshes;

or, the method comprises the steps of: mixing the above components at a certain ratio, decocting with water 8-12 times of the weight of the medicinal materials for 1.5-2.5 hr, decocting with water 6-10 times of the weight of the medicinal materials for 1-2 hr, and filtering; preferably, concentrating the filtrate at 50-70 ℃ to obtain an extract with the relative density of 1.2-1.25;

or, the method comprises the steps of: mixing the above components at a certain ratio, soaking in 55-75% ethanol 4-12 times the weight of the raw materials for 12-48 hr, heating the medicinal liquid to 30-40 deg.C, and forcibly circulating for 3-4 hr.

6. A preparation containing the Chinese medicinal composition of any one of claims 1 to 4, wherein the preparation is prepared from the Chinese medicinal composition alone; or comprises a traditional Chinese medicine composition and a pharmaceutically acceptable carrier; or comprises a traditional Chinese medicine composition and auxiliary materials, wherein the auxiliary materials are one or more of dextrin, lactose, sucrose and soluble starch.

7. The formulation of claim 6, wherein the formulation is a granule, capsule, pill, or suppository.

8. A method of preparing the formulation of claim 6 or 7, comprising the steps of:

(1) preparing a traditional Chinese medicine composition;

9. Use of a Chinese medicinal composition according to any one of claims 1 to 4 or a formulation according to claim 6 or 7 in the manufacture of a medicament for the treatment of ulcerative colitis.

10. The use according to claim 9, wherein the ulcerative colitis is severe ulcerative colitis or refractory ulcerative colitis.